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CivaTech Oncology receives $2.3m from NIH for pancreatic cancer study with CivaSheet device

CivaTech Oncology has received a notice of award from the NIH NCI SBIR Fast Track program for the first phase of an 80 patient, multi-center pancreatic cancer study with the new FDA cleared CivaSheet device.

The two-year study, beginning in 2016 will track important safety and efficacy benefits of a new, highly targeted radiation treatment device for patients with pancreatic cancer.

Each year approximately 45,000 patients are diagnosed with pancreatic cancer in the United States. Of those diagnosed with the disease, approximately 12,000 will be candidates for the potentially lifesaving “Whipple” surgical tumor resection procedure.

Despite decades of research, the overall prognosis for cancer recurrence and 5-year survival rates are dismal. Standard of care includes radiation treatment for patients. Radiation oncologists are limited in the radiation dose they can give to patients due to the proximity of healthy tissue and critical organs to the affected area, and the toxicity (side effects) resulting from unintended radiation dose to these areas from other radiation treatment methods.

In the study, patients undergoing the Whipple surgical procedure will be given a highly targeted boost of radiation dose by an implant of the CivaSheet, directly to close surgical margins that are prone to recurrence.

Because this boost can be given without increasing radiation dose to healthy tissue or organs, the overall radiation dose a patient receives to these margins will be increased. The study will track the effectiveness of this new approach in preventing cancer recurrence.

“The option to treat patients with a directional radiation implant using the CivaSheet may allow us to increase the safe dose of radiation in this setting, controlling disease that would otherwise come back. Our team is eager to begin studying this device on a clinical trial” – Joshua Meyer, MD. Principal Investigator and Assistant Professor of Radiation Oncology at Fox Chase Cancer Center (Philadelphia, PA)

CivaSheet® is a flexible, Palladium-103 low-dose rate (LDR) implantable intra-operative brachytherapy device, which emits directional radiation by integrating gold shielding. The CivaSheet is implanted in a 15-minute procedure at the end of a surgical resection. The directional property makes the device active on one side only, and is entirely unique to CivaSheet.

This allows physicians to deliver aggressive radiation doses immediately adjacent to healthy, sensitive tissue.

Most of the CivaSheet is naturally absorbed by the body. No follow-up procedure is necessary to remove the device. CivaSheet received FDA clearance in 2014 and development was partially funded by the NIH and NC Biotech Center.